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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03666026
Other study ID # 17-001889
Secondary ID 1R01AI135029-01
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2018
Est. completion date April 2, 2019

Study information

Verified date October 2021
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System. Despite the Advisory Committee on Immunization Practices (ACIP) recommendation in 2010 that all people above 6 months of age should receive an annual flu vaccine, vaccination rates remain low: at 6m-4.9 yrs. (70%), 5-17.9 yrs. (56%), 18-64.9 yrs. (38%), and >65 yrs. (63%). The investigators will assess the effectiveness and cost-effectiveness of 1, 2, 3 MyChart R/R messages as compared to the standard of care control (no messages).


Description:

Annual epidemics of influenza cause substantial morbidity in the U.S. with up to 40,000 deaths/year and many hospitalizations, emergency and outpatient visits, and significant costs. Concerns about pandemic influenza elevate the need to prevent flu outbreaks. Numerous studies, including Cochrane or systematic reviews, and reports by the CDC and the Task Force on Community Preventive Services, highlight 4 evidence-based strategies to raise child and adult influenza vaccination rates: 1) increase patient demand by reminder-recall or education, 2) expand patient access to influenza vaccinations (e.g., flu vaccine clinics), 3) implement provider strategies such as prompts or standing orders, and 4) use societal strategies (e.g., reducing costs). Reminder/recall (R/R), sent by phone, mail or other modality, can improve child and adult influenza vaccination rates. However, fewer than one-fifth of pediatric or adult primary care practices utilize patient R/R. Barriers are lack of finances, personnel, and algorithms to identify eligible patients. A technological breakthrough that might overcome these barriers involves patient portals-- secure, web-based communication systems, embedded within electronic health records (EHRs), for patients and providers to communicate with each other via email and the internet. Portals are used by about half of Americans and half of UCLA patients. Portals can theoretically improve upon phone, mail or text R/R by adding information such as web links, videos, or images, allowing patients to schedule their own visits, and linking to the medical chart to customize messages. For this randomized control trial, the intent is to evaluate the impact of patient portal (MyChart) reminder recalls - either 1, 2, or 3 reminders versus the standard of care control group, specifically in relation to raising influenza vaccination rates among UCLA Health System's primary care patients aged 6 months and older. The proposed design of this 4-arm RCT: 1. Standard of care control (no messages) 2. Up to 1 portal R/R messages 3. Up to 2 portal R/R messages 4. Up to 3 portal R/R messages Hypothesis 1: >1 portal R/R will increase vaccination rates vs. no R/R. Hypothesis 2: More R/R messages will raise vaccination rates (3R/R > 2R/R > 1R/R > 0R/R). For the primary analysis, only the data from the randomly selected index patients (1 index patient per household) will be included. For relevant study arms, the first R/R message will be sent in October 2018.


Recruitment information / eligibility

Status Completed
Enrollment 164205
Est. completion date April 2, 2019
Est. primary completion date April 2, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Months and older
Eligibility Inclusion Criteria: • A patient within the UCLA Health System identified by the system as a primary care patient per an internal algorithm, with a documented primary care visit within the last 3 years as of 8/1/18. Exclusion Criteria: • A patient not identified by the UCLA Health System's internal algorithm as a primary care patient.

Study Design


Intervention

Behavioral:
1 MyChart R/R
Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
2 MyChart R/R
Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
3 MyChart R/R
Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.

Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1.Receipt of the Annual Influenza Vaccine (Between 10/1/18 - 4/2/19) Among Index Patients. Outcomes Will be Assessed Via Vaccine Data Extraction From the Electronic Health Record and External Claims and Pharmacy Data. Number of participants in each arm who received influenza vaccination October 1, 2018 to April 2, 2019 during influenza vaccination season
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